Ex Parte Lea et al

Patent Trials and Appeals Board

Mar 29, 2019

11632872 - (D) (P.T.A.B. Mar. 29, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
11/632,872 02/06/2008 Peter Lea
24247 7590 04/02/2019
TRASKBRITT, P.C.
P.O. BOX 2550
SALT LAKE CITY, UT 84110
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
3627-8170US 1557
EXAMINER
FOSTER, CHRISTINE E
ART UNIT PAPER NUMBER
1641
NOTIFICATION DATE DELIVERY MODE
04/02/2019 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
USPTOMail@traskbritt.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PETER LEA, THOMAS G. EWART,
STUART X. CARMICHAEL, and CLAUDE RICKS
Appeal2018-004476
Application 11/632,872
Technology Center 1600
Before ULRIKE W. JENKS, TIMOTHY G. MAJORS, and
MICHAEL A. VALEK, Administrative Patent Judges.
JENKS, Administrative Patent Judge.
DECISION ON APPEAL
Appellants 1 submit this appeal under 35 U.S.C. § 134(a) involving
claims directed to a method of optimizing the detection of an analyte in a
sample. Examiner rejected the claims as indefinite, containing new matter,
lacking written descriptive support, and obviousness. We have jurisdiction
under 35 U.S.C. § 6(b ).
We AFFIRM.
1 Appellants identify the Real Party in Interest as SQI Diagnostic Systems
Inc. Br. 2. We have considered, and herein refer to, the Specification of
Jan. 19, 2007 ("Spec."); the Non-Final Office Action of April 10, 2017
("Office Act."); the Appeal Brief of Nov. 13, 2017 ("Appeal Br."); and the
Examiner's Answer of Jan. 17, 2018 ("Ans.").
Appeal2018-004476
Application 11/632,872
STATEMENT OF THE CASE
Claims 1-3, 5, 9, 12-16, 19, and 23-25 are on appeal, and can be
found in the Claims Appendix of the Appeal Brief. Claim 1, the sole
independent claim, is representative of the claims on appeal, and reads as
follows:
1. A method of optimizing an assay for detecting a
concentration of an analyte in a sample test fluid, said assay
employing a chip assay device having a surface, the surface
having a plurality of site specific immobilized calibration dots
including pre-determined quantities of the analyte printed
thereon and a plurality of test spots including a capture
antibody for binding said analyte, said method including the
following steps:
modifying said surface by applying an epoxysilane
coating to provide hydrophobic binding sites, hydrophilic
linking sites and covalent linking sites;
printing said test spots and said calibration dots on said
surface under conditions of constant relative humidity in the
range of 15%; to 90%, wherein the capture antibody to be
printed as the test spots are suspended in a first modulation
buffer and the analyte to be printed in as the calibration dots are
suspended in a second modulation buffer, and wherein each of
the calibration dots and the test spots are substantially similar in
morphology and size;
applying the sample test fluid to the chip assay device;
testing a sensitivity of the chip assay device for detecting
analyte in the sample test fluid;
baking the epoxysilane coating;
modulating the ratio of said hydrophobic binding sites to
said hydrophilic linking sites to said covalent linking sites by
modulating baking time and temperature of the epoxysilane
coating in order to optimize the sensitivity of the assay; and
wherein each of the calibration dots and test spots
remains substantially similar in morphology and size after
testing the sensitivity of the chip assay device.
Br. 14 (Claims Appendix) (emphasis added).
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Application 11/632,872
Appellants request review of the following rejections made by
Examiner:
I. Claim 1 under 35 U.S.C. § 112, first paragraph as failing to
disclose calibration dots that remain substantially similar in morphology
and size, this is a new matter rejection.
II. Claim 1 under 35 U.S.C. § 112, first paragraph as failing to
show possession of genus of calibration dots that are substantially similar
in size and morphology, this is a written description rejection.
III. Claims 1-3, 5, 9, 12-16, 19, and 23-25 under 35 U.S.C. § 112,
second paragraph as being indefinite with respect to the disclosure of
calibration dots that are substantially similar in size and morphology.
IV. Claims 1, 2, 5, 9, 12-16, and 19 under 35 U.S.C. § 103(a) as
unpatentable over Rupcich2 in view of Tzeng, 3 Miyamoto, 4 Dordick, 5
and Huang. 6
2 Rupcich et al., Optimization of Sol-Gel Formulations and Surface
Treatments for the Development of Pin-Printed Protein Microarrays, 15
CHEM. MATER. 1803-11 (2003)(" Rupcich").
3 Tzeng et al., US 2003/0059819 Al, published Mar. 27, 2003 ("Tzeng").
4 Miyamotao et al., US 2002/0015800 Al, published Feb. 7, 2002
("Miyamoto").
5 Dordick et al., US 2003/0162284 Al, published Aug. 28, 2003 ("Dordick").
6 Huang, Simultaneous Detection of Multiple Proteins with an Array-Based
Enzyme-Linked Immunosorbent Assay (ELISA) and Enhanced
Chemiluminescence (ECL), 39 CLINCHEMLABMED. 209-14 (2001).
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Application 11/632,872
V. Claims 1, 2, 5, 9, 12-16, 19, and 24 under 35 U.S.C. § 103(a) as
unpatentable over Rupcich in view of Tzeng, Miyamoto, Dordick,
Huang, Mann, 7 and Selitrennikoff. 8
VI. Claim 3 under 35 U.S.C. § 103(a) as unpatentable over Rupcich
in view of Tzeng, Miyamoto, Dordick, Huang, and further in view of
Shanks; 9 or alternatively over Rupcich in view of Tzeng, Miyamoto,
Dordick, Huang, Mann, and Selitrennikoff and further in view of Su,
Shanks.
VII. Claim 23 under 35 U.S.C. § 103(a) as unpatentable over
Rupcich in view of Tzeng, Miyamoto, Dordick, Huang, and further in
view of Su; 10 or alternatively over Rupcich in view of Tzeng, Miyamoto,
Dordick, Huang, Mann, and Selitrennikoff and further in view ow Su.
VIII. Claim 25 under 35 U.S.C. § 103(a) as unpatentable over
Rupcich in view of Tzeng, Miyamoto, Dordick, Huang, and further in
view of Okamoto 11 and Wang; 12 or alternatively over Rupcich in view of
Tzeng, Miyamoto, Dordick, Huang, Mann, and Selitrennikoff and further
in view of Okamoto and Wang.
7 Mann et al., Production of Protein Microarrays, IN PROTEIN MICROARRAY
TECHNOLOGY, editor Kambhampati (2004) ("Mann").
8 Selitrennikoff et al., US 2002/0177182 Al, published Nov. 28, 2002
("Selitrennikoff').
9 Shanks et al., US 4,978,503, issued Dec. 18, 1990 ("Shanks").
10 Su et al., US 2005/0181379 Al, published Aug. 18, 2005 ("Su").
11 Okamoto et al., EP O 895 082 A2, published Feb. 3, 1999 ("Okamoto").
12 Wang et al., A genotyping system capable of simultaneously analyzing
> 1000 single nucleotide polymorphisms in a haploid genome, 15 GENOME
RESEARCH 27 6-83 (2005).
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Application 11/632,872
1.-11. Written Descriptions I New Matter
Examiner rejected claim 1 under pre-AIA 35 U.S.C. § 112, first
paragraph, as lacking adequate written description for the limitation "each of
the calibration dots and test spots remains substantially similar in
morphology and size after testing." Examiner finds that the limitation is not
described in the Specification. Ans. 5. Examiner explains that the limitation
"sets forth a desired result, without specifying how the result is achieved."
Id. Specifically, Examiner finds that
maintaining spot size and morphology would depend on
numerous variables, such as the concentration of analyte or
antibody, the particular analyte or antibody and its integrity,
arrayer settings like printing depth, the fluorophore and imaging
process used, the particular washing procedures, etc.
Id. Examiner acknowledges that the Specification recites "a particular
buffer, namely 50 mM H3B03, pH 5.0, in most cases with 50 mM MgCh
added" to achieve the best dot morphology, while other buffers produce
erroneous results. Id. at 5---6. Examiner, however, notes that the claims are
not limited to this particular buffer system.
Examiner's new matter rejection is directed to the same limitation at
issue in the written description rejection. See Ans. 4; see Office Act. 6. 13
Thus, our decision as to the written description rejection also disposes of the
corresponding new matter rejection because the two rejections in this
instance are interrelated. See MPEP 608.04 ("If the new matter has been
entered into the claims or affects the scope of the claims, the claims affected
13 Examiner, in the same Office Action, also rejected the recitation of "a first
modulation buffer" and "a second modulation buffer" as being directed to
new matter. Office Act. 6. This rejection has now been withdrawn. See
Ans. 24.
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Application 11/632,872
should be rejected under 35 U.S.C. 112(a) because the new matter is not
described in the application as originally filed."), see MPEP 2159.01.
Appellants contend that in order to satisfy the written description
requirement the Specification need only to provide sufficient detail to
apprise one of ordinary skill in the art to "reasonably conclude that the
inventor had possession of the claimed invention." Br. 6-7 (citing Moba, H
V v. Diamond Automation, Inc., 325 F.3d 1306 (Fed. Cir. 2003)).
Appellants contend that one of ordinary skill in the art would have
concluded that the phrase is adequately described in the Specification. Id. at
8 ( citing Lea Declaration 14). Specifically, Appellants rely on Figure 10 of
the Specification to establish that different buffers maintain dot form and
morphology before and after testing. Id. With respect to the new matter
rejection, Appellants contend that there is "no in haec verba requirement,
newly added claim limitations," instead support may found either through
express, implicit, or inherent disclosure. Id. at 3.
"[T]he written description requirement does not demand either
examples or an actual reduction to practice; a constructive reduction to
practice that in a definite way identifies the claimed invention can satisfy the
written description requirement." Ariad Pharm., Inc. v. Eli Lilly & Co., 598
F.3d 1336, 1352 (2010). The disclosure, however, must convey with
reasonable clarity to those skilled in the art that the inventor was in
possession of the invention. See Purdue Pharma L.P. v. Faulding, Inc., 230
F.3d 1320, 1323 (Fed. Cir. 2000). The written description requirement
"serves a teaching function, as a 'quid pro quo' in which the public is given
14 Declaration under 37 C.F.R. § 1.132 by Dr. Peter Lea signed Dec. 7, 2016.
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'meaningful disclosure in exchange for being excluded from practicing the
invention for a limited period of time."' Univ. of Rochester v. G.D. Searle &
Co., 358 F.3d 916, 922 (Fed. Cir. 2004). In this case, the Specification does
not provide a meaningful disclosure of the invention to the public in return
for the grant of a patent, failing to satisfy the basic quid pro quo underlying
the patent system.
According to the Specification, "[p ]rinting, on the modified surface,
of the calibration and test dot analytes suspended in modulation buffer
containing molecular spacer, is carried out under constant humidity control
to ensure that the spots tend to minimal thickness leading to the formation of
molecular layer thickness site-specific immobilized arrays of test spots."
Spec. 11: 12-15. Figure 2, reproduced below, shows spot morphology of
different print buffers on an epoxy substrate with different concentrations of
analyte.
"Figure 2 shows a dot morphology of 10 different print buffers on epoxy
substrate. Eight dilutions (5x) of BPA were printed in triplicate from the
maximum of 1000 µg/ml at left to 0.0 at right." Spec. 12:20-23.
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Application 11/632,872
Figure 10 of the Specification, reproduced below, shows the effect of
the buffer on the distribution of analyte within a dot.
0
...
. .
.. .
.
·o·-... · .. ·' : ... . ·... >
. ·~ ..
A B C D
Figure 10 character A, shows the effect of using bicarbonate
buffer at pH 9.0 to form a central aggregate of concentrated
analyte which causes an emission peak and erroneous data
results. Character B shows the effect of additional guanidine
hydrochloride which causes dispersed analyte aggregates.
Character C shows the use of borate and guanidine hydrochloride
at pH 5.0. The formation of an annulus of analyte at the
perimeter of the spot, leaving the centre [sic] a minimal
concentration is shown. Surprisingly, the molecular spacer
component of the present invention, Figure 10 at character D
forms the best spot morphology and signal. The analyte is evenly
dispersed throughout the spot using borate ( 50 mM H3BQ3, pH
5.0), but adding 5 Magnesium Chloride (50 mM MgC2) to
actively space the analyte throughout the spot.
Spec. 18:24 to 19:6.
Thus, the Specification provides that the buff er composition as well as
the concentration of analyte affect the size of the spot. Compare Spec.
Fig. 2 (reproduced above) and Fig. 10 (reproduced above).
Appellants rely on Figure 10 of the Specification as showing that the
use of different buffers allows the dots to maintain size and morphology
after testing. Br. 7. "[ A ]ppellants note that the spots would not be visible in
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Application 11/632,872
Fig, 10 unless their sensitivity to the viewing agent (fluorescently labeled
antibody specific for the printed analyte) was also tested." Id.
With respect to Figure 10, Examiner finds that the figure does "not
depict any test spots (having capture antibody) nor does it compare dots/
spots before and after testing sensitivity." Ans. 28. We agree with
Examiner that Figure 10 of the Specification is not sufficient to establish that
a test spot ( or calibration spot) remains constant because the figure does not
disclose a test spot at all, and does not show a calibration spot before testing
is completed. See id. Therefore, as acknowledged by Appellants, the only
disclosure in the Specification shows spots that are already tested for
sensitivity, in other words showing morphology and size of spots after
testing. See Br. 7 ("spots would not be visible ... unless their sensitivity to
the viewing agent ... was also tested"). Because Figure 10 does not allow
for a comparison of the spots before testing, the Specification does not
demonstrate that the inventors were in possession of a method wherein the
morphology and size of each of the calibration dots and spots "remains
substantially similar after testing," as claimed. Therefore, we agree with
Examiner, that these disclosures in the Specification are insufficient support
the limitation of "remains substantially similar in size and morphology" as
recited in claim 1.
Appellants also rely on the Lea Declaration to support their position
that the Specification is adequate to demonstrate that the calibration and test
spots retain their size and morphology. Br. 8. Dr. Lea attests that "Fig. 10
( as described in ,r [ 0081]) demonstrates in set D that retention of
morphology and size after testing can be obtained using the teachings of the
'872 application." Lea Dec. ,r 7 (emphasis added). Although, the
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Application 11/632,872
"description need not recite the claimed invention in haec verba but [the
description] must do more than merely disclose that which would render the
claimed invention obvious." ICU Medical, Inc. v. Alaris Medical Systems,
Inc. 558 F.3d 1368, 1377 (Fed. Cir. 2009).
We agree with Examiner that the Lea Declaration is not sufficient to
establish that the presently claimed limitation is adequately described in the
as filed Specification for one of ordinary skill in the art to conclude that the
written description requirement is satisfied. See Ans. 29. Indeed, the Lea
Declaration merely suggest that "the retention of morphology and size"
could be determined given the disclosure. Lea Dec. ,r 7. Providing a road
map on how one might obtain a particular piece of information in not the
same as providing a sufficiently meaningful disclosure to convey with
reasonable clarity to those skilled in the art that the inventor was in
possession of the invention as presently claimed. We agree with Examiner's
conclusion that the Specification does not provide sufficient written
descriptive support for the limitation "each of the calibration dots and test
spots remains substantially similar in morphology and size after testing."
Because there is insufficient written descriptive support for this limitation,
we also agree with Examiner's new matter rejection.
Accordingly, we affirm the rejection of claim 1 as not finding
adequate written descriptive support in the as filed Specification, and that
the addition of the limitation to the claims constitutes new matter.
III. Indefiniteness
The issue for this rejection is does the limitation "substantially similar
in morphology and size after testing" render the claims indefinite?
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Examiner finds that claim 1 is indefinite because "[t ]he recited
functions (substantially similar in morphology and size after testing) could
be impacted by numerous different factors" such as analyte or antibody,
printing depth, and fluorophore. Ans. 9. Each of these factors can impact
the spot size and morphology. Id. Examiner explains that "the boundaries
of the [ substantially similar] functional language at issue are unclear because
claim does not provide a discemable boundary as to what achieves the
function." Id. at 29.
Appellants contend that the claim limitation "substantially similar in
morphology and size after testing" is adequately described in the
Specification as understood by one of skill in the art. Br. 7-8 ( citing Spec.
18:24 to 19:15, Figure 10, and the Lea Declaration).
A claim does not comply with 35 U.S.C. § 112, second paragraph,
"when it contains words or phrases whose meaning is unclear." In re
Packard, 751 F.3d 1307, 1310, 1314 (Fed. Cir. 2014) (approving, forpre-
issuance claims, the standard from MPEP § 2173.05(e)); see also Ex parte
McAward, Appeal 2015-006416, 2017 WL 3669566, at *5 (PTAB Aug. 25,
2017) (precedential) (adopting the approach for assessing indefiniteness
approved by the Federal Circuit in Packard). We understand that words of
degree may lack precision, but they do not necessarily render a claim
indefinite. Seattle Box Co., Inc. v. Indus. Crating & Packing, Inc., 731 F.2d
818,826 (Fed. Cir. 1984) (A term of degree is definite if the specification
"provides some standard for measuring that degree .... that is, whether one
of ordinary skill in the art would understand what is claimed when the claim
is read in light of the specification."). Here, the Specification does not
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provide a way for measuring the acceptable boundaries encompassed by the
phrase, thereby, rendering the claims vague and indefinite.
Appellants rely on Figure 1 OD of the Specification to show "spots that
retain substantially similar morphology and size after testing." Br. 8.
Appellants' arguments do not persuade us that Examiner's rejection is in
error. See Ans. 29 ("the boundaries of the [ substantially similar] functional
language at issue are unclear because claim does not provide a discemable
boundary as to what achieves the function."). As Examiner explains, "Fig.
10 [does] not depict any test spots (having capture antibody) nor does it
compare dots/ spots before and after testing sensitivity," thus, this disclosure
does not provide a basis for comparison upon which to evaluate any
similarity. Id. at 28. Reliance by Appellants on the Lea Declaration is
inadequate because the Declaration merely suggests that "the retention of
morphology and size" could be obtained given the disclosure. See Br. 7-8;
see Lea Dec. ,r 7. We agree with Examiner that the Specification does not
provide detail sufficient to establish with reasonable certainty the boundaries
of change that are acceptable to still meet the "substantially similar" size and
morphology requirement.
In the absence of any intrinsic or extrinsic evidence as to the scope of
the term, we find "remains substantially similar in morphology and size after
testing" is amenable to any number of plausible claim constructions. The
Specification shows that depending on analyte load the spot can have
varying sizes after testing. See Spec. Figure 2 (reproduced above). The
Specification does not provide a comparison of the same spot/ dot at two
different time points in the process from which to determine if the
morphology and size remains "substantially similar." The Specification
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provides that the spots are spaced 340 microns apart (Spec. 14:29) and the
spots themselves can range in size from 160 to 250 microns (Spec. 14: 15).
Merely reciting the size of the spots and the distance between the spots as
disclosed in the Specification does not define what is reasonably
encompassed by the limitation "substantially similar in morphology and size
after testing." At best one of skill in the art could speculate that similar size
is somewhere between no change up to a spot size increase that would allow
two adjacent spots to bleed into another. Accordingly, we agree with
Examiner that phrase "substantially similar" in the context of the claims is
indefinite. See Ex parte McAward, Appeal 2015-006416, 2017 WL
3669566, at *2 (citing Ex parte Miyazaki, 89 USPQ2d 1207, 1211 (BPAI
2008) (precedential) ("[During prosecution,] if a claim is amenable to two or
more plausible claim constructions [ upon giving it the broadest reasonable
interpretation consistent with the Specification], the USPTO is justified in
... holding the claim unpatentable ... , as indefinite."). We agree with
Examiner that, without more, the meets and bounds of the limitation
"substantially similar in morphology and size" cannot be reasonably
ascertained and would not be reasonably understood by the ordinarily skilled
person. Accordingly, we affirm Examiner's rejection under pre-AIA
35 U.S.C. § 112, second paragraph as being indefinite.
IV.-VIII.
Huang
Obviousness over Rupcich, Tzeng, Miyamoto, Dordick, and
Each of the rejections IV-VIII relies on the underlying combination of
Rupcich, Tzeng, Miyamoto, Dordick, and Huang. Because the same issue is
dispositive for all of these rejections, we will consider the rejections
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together. Specifically, all of these rejections rely upon the teaching of
Rupcich to arrive at the limitation that "'each of the calibration dots and test
spots remains substantially similar in morphology and size after testing the
sensitivity of the chip assay device" as recited in claim 1.
Appellants contend that the combination of references does not meet
all claim limitations. Br. 10. Appellants contend that "Rupcich does not
teach or suggest that 'each of the calibration dots and test spots remains
substantially similar in morphology and size after testing the sensitivity of
the chip assay device' as recited by claim 1." Id. "[A] comparison between
Figure 4(B) and Figure 4(C) ... , the test spots [ of Rupcich] do not remain
substantially similar in morphology after testing." Id. ( citing Lea
Declaration).
Examiner finds that Rupcich teaches "glass slide microarrays having
proteins printed on their surface." Ans. 10. Examiner finds that Rupcich's
dot/spots are substantially similar in size and shape "when this terminology
is given its broadest reasonable interpretation, in that the spots can be
discerned as substantially spherical against background, corresponding to the
size and shape as originally arrayed by the pin-printer." Id. at 12 (citing
Rupcich Figure 4). Examiner finds that the Lea Declaration is not
persuasive because it "does not explain in any detail the experimental
procedures of Fig. 1 OD [ of the Specification] or set forth how this is an apt
comparison with Rupcich 4C" to reasonably conclude that Rupcich
experimental procedure results in calibration dots and test dots that
substantially differ in size and appearance. Id. at 32.
In light of the rejection for indefiniteness as addressed above (III),
substantial confusion exists in the record as to the proper interpretation and
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scope of the appealed claims. Because the meets and bounds of what is
encompassed by "sufficiently similar" in the context of the morphology and
size of the calibration and test spots, we are unable to discern if the prior art
is within the scope of Appellants' claims. Rather than speculate further
about how the present claims compare to the method(s) and result(s)
disclosed in the cited prior art, we reverse pro forma the obviousness
rejections under 35 U.S.C. § 103 at this time. Cf In re Steele, 305 F.2d 859,
863 (CCPA 1962) ("We believe that this confusion arose and has continued
because the claims do not particularly point out and distinctly claim the
invention as required by 35 U.S.C. § 112."). This is a proforma reversal
and does not limit the citation of the same ( or different) prior art against the
claims in the future, should the rejections under§ 112 be overcome through
continued prosecution. As in Steele, "[ o ]ur decision is not to be construed as
meaning that we consider the claims on appeal to be patentable [ over the
prior art] as presently drawn." Id.
Accordingly, we reverse all rejections that rely on the combination of
Rupcich, Tzeng, Miyamoto, Dordick, and Huang.
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SUMMARY
We affirm the rejection of claim 1 under 35 U.S.C. § 112, first
paragraph as reciting new matter.
We affirm the rejection of claim 1 under 35 U.S.C. § 112, first
paragraph as failing describe the subject matter as claimed.
We affirm the rejection of claims 1-3, 5, 9, 12-16, 19, and 23-25
under 35 U.S.C. § 112, second paragraph as being indefinite.
We reverse proforma all obviousness rejections.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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